The primary aim of this study is to compare the efficacies of clinical treatments for the group of chronic, painful functional bowel disorders (FBD) that predominantly affect women. Secondary aims include 1) determination of demographic, psychosocial, physiologic and symptomatic predictors of clinical improvement and 2) analysis of significant relationships among physiologic markers of FBD, psychosocial status, symptoms and treatment effects. The Principal Investigator and his colleagues propose to compare cognitive-behavioral psychological treatment with antidepressant drug therapy (desipramine) and education/attention placebo in over 300 women. Interrelationships between psychological and physiological factors on the development, clinical expression and treatment of FBD have long been recognized, but this is the first large-scale study designed both to isolate therapeutic effects, and to investigate interactions among physiologic measures, psychologic and sociodemographic factors, severity of symptoms, and therapeutic improvement including quality of life. In the proposed plan of research, at least 300 female patients (aged 18- 65) with FBD (irritable bowel syndrome, painful constipation and/or functional abdominal pain) will be enrolled in clinics at UNC-Chapel Hill and Toronto, Canada. A severity index will determine recruitment into the group of moderate FBD (200 patients) and severe FBD (100 patients). Each group will be randomized into the three treatment arms (cognitive- behavioral treatment, desipramine, and education/attention placebo), treated over a 12-week period, and followed for one year. Outcome measures will include symptoms (standardized abdominal pain, stool form, and frequency) using diary cards, daily functional status (Sickness Impact Profile), depression (HAM-D), and psychological distress (SCL-90), physiological measures (enhanced rectal motility and visceralsensation), and health care use. Multivariate statistical methods with a hierarchical design will be applied to the data to assure maintenance of statistical power over multiple tests of overlapping groups. The results of this study may significantly improve an understanding of this complicated syndrome that lowers the quality of life and economic productivity of large numbers of women. The clinical impact of the study, in providing physicians with scientific evidence of the efficacy of treatments of FBD that are commonly used in practice, may be significant. This study may provide clinicians with predictors of success among types of FBD patients and types of therapy that will improve symptoms and quality of life and reduce the health care costs associated with this common syndrome, while improving patient-physician satisfaction.
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